US20120210678A1 - Method and apparatus for sharps protection - Google Patents

Abstract

Devices and methods are disclosed for protecting individuals from the sharp ends of medical objects following use on a patient. Such sharp objects include hypodermic needles, scalpel blades, cannulae, trocars, and the like. The invention utilizes a disposable protective cover for the used sharp. The protective cover is designed to surround and embed the sharp in a permanent cover that is blunt and will not permit further puncture or cutting with the sharp. In an embodiment, the protective cover also absorbs any fluids on or in the used sharp and prevents any fluids from escaping the protective cover. The sharp cover is configured to irreversibly lock, once closed. A refillable or replaceable dispenser dispenses the protective covers at points of use. A disposable receptacle receives the used sharp embedded in the protective cover. When the receptacle is full, the entire receptacle may be discarded in a medical waste container.

Description

RELATED APPLICATIONS
• This application claims priority benefit from, and is a continuation-in-part of, U.S. patent application Ser. No. 12/456,648, filed on Jun. 19, 2009, which is a continuation-in-part of U.S. patent application Ser. No. 10/862,694, filed on Jun. 7, 2004, which claims priority benefit under 35 USC §119(e) from U.S. Provisional Application No. 60/477,121, filed on Jun. 9, 2003, entitled “METHOD AND APPARATUS FOR SHARPS PROTECTION”, the entirety of all of which are hereby incorporated herein by reference.
FIELD OF THE INVENTIONS
• This invention relates to devices and methods to protect individuals from infectious disease spread due to puncture wounds made by sharp, contaminated objects. More particularly, the invention relates to a protective container for safely sequestering and disposing of used medical sharps.
BACKGROUND OF THE INVENTION
• Pathogenic microorganisms may be present in human blood, body fluids or other infected materials and can cause infection and disease in persons who are percutaneously, or mucocutaneously, exposed. These pathogens include, but are not limited to, hepatitis B virus (HBV), hepatitis C virus (HCV) and human immunodeficiency virus (HIV). In this context, contaminated blood, body fluids or other infected materials may mean the presence or reasonably anticipated presence of pathogenic microorganisms on the surface or in a device.
• A medical sharp is an object that can penetrate the skin and includes devices such as, but not limited to, needles, scalpels, tubes, wires, and other medical procedure objects, devices or instruments. Accidental puncture with contaminated, sharp needles or surgical instruments, referred to as medical sharps or sharps, remains a significant risk to healthcare workers. All healthcare workers, such as physicians, nurses, paramedics, emergency medical technicians, ambulance staff, airmedics, airmedic staff technicians, janitorial staff, office staff, and even patients and their families, are potentially at risk from this dangerous situation.
• Typically, injuries resultant from accidental needle and scalpel sticks occur after the instruments have been used. As a result, healthcare workers are subject to serious diseases, including but not limited to hepatitis B virus (HBV), hepatitis C virus (HCV) and human immunodeficiency virus (HIV).
• Most often, needle and scalpel punctures occur during the handling of used sharp instrumentation prior to permanent disposal. Healthcare workers can accidentally stick themselves or others in the vicinity while carrying contaminated instruments to a centrally located disposal container for used sharps. Often, needles dangerously protrude from the designated container, often located on a peripheral wall of a given room and often located behind furniture, fixtures, and medical equipment. This increases the risk of puncture to the healthcare worker placing the sharp in the container, or emptying the used sharps container.
• The true cost of the problem is difficult to measure. For every “needlestick” exposure, the health care worker is subjected to batteries of tests that are repeated3 to4 times over the following year. If the risk is determined to be substantial, in terms of exposure to known or likely HIV, Hepatitis, or other pathogens, there may also be medication costs involved. There are side effects to medications administered for suspected disease transmission and the costs, both societal and monetary, are significant for such treatments. If a disease is actually transmitted by the event, the costs, both personal and financial, are staggering, and the event can prove to be career ending as well as adversely affecting the family and social life of the healthcare worker. Disease transmission, in the worst scenario, can be life ending for the exposed healthcare worker. Bearers of these costs, both tangible and intangible, include health care organizations, their insurers, governmental agencies, the health care workers and their families, and society as a whole.
• Current solutions in the prior art include needle guards and covers, retractable needles, scalpel protectors and needleless connecting systems for intravenous solutions.
• Although needle guards and covers, needles and needleless systems address part of the solution to the problem, they do not offer a universal solution that will manage the risks posed by other types of medical sharps, including scalpel blades, trocars, and the like.
• The prior art includes protective devices for sharps. These are intended to enclose and blunt the used sharp, which prevents anyone from coming into contact with the contaminated sharp.
• Current portable sharps containment devices accommodate needles, but may not accommodate thick sharps, such as cannulae, trocars, scalpels, hypodermic needles with an attached syringe barrel, and the like. It is generally against hospital policy and good medical practice to attempt to remove a sharp from its handle or syringe barrel because of the risk of needlestick or skin puncture and resultant contamination. Typically, sharps containment devices comprise a soft enveloping material having inadequate puncture resistance. In addition, current sharps containment devices may leak contaminated bodily fluids from the used sharp. Medical care facilities typically locate the sharps receptacle at a peripheral location within an area or room, and not at the point-of-use. There may be significant obstacles between the user and the sharps receptacle, including patient gurneys, beds, or examining tables; persons, such as patients, family members, visitors, and other health care workers; medical equipment such as IV poles and lines, monitors, wires, tubes, and other devices; or other furniture, fixtures, and equipment. This again creates the problem of the healthcare worker sticking a co-worker while moving the contaminated sharp to the disposal receptacle.
• A typical sharps collector and disposal device is a mailbox-style container with or without a pull-down opening allowing access to the container. The user pulls the lid open, deposits the used sharp, and releases lid, which swings shut, much like mailing a letter. Mailbox-style containers without the pull-down opening have a tortuous path that the sharp must traverse to enter the container. The mailbox-style containers can be found in a variety of sizes and uses, such as in-hospital room containers, multi-purpose containers, mail-away containers, large volume and pharmacy containers, specialized containers, transportable containers, and the like.
• A typical problem with mailbox-style receptacles is that they are frequently overfilled with needles, such that the needles stick out of the container opening. In addition, it may be difficult to put certain types of sharps, such as butterfly needles, needles attached to syringes, suture needles, trocars, cannulae, and the like, into them. An overfilled mailbox-style receptacle may result in healthcare workers becoming cut and infected by an already disposed-of sharp when they try to insert a new sharp into the receptacle and force their hand on the protruding sharp object, or by the new sharp itself. An additional risk of the mailbox-style receptacle includes the user being stuck as the sharp is being placed into the unit due to the difficulty of inserting the sharp into the tortuous pathway opening.
• Not only are health care workers themselves at risk because of inadequate or unsafe disposal systems, but there are significant risks to housekeeping personnel within healthcare institutions and even to the public, who may encounter an improperly disposed, contaminated, unprotected, medical sharp device. Areas at risk include in-patient hospitals, outpatient facilities, emergency or ambulatory facilities, patient homes, offices, public restrooms, physician's offices, nursing homes, laboratories, emergency medical facilities, military facilities, helicopters, airplanes, airmedic facilities, employer facilities, hospice care facilities, needle dispensing facilities for heroin addicts and diabetics, and the like. Unprotected contaminated medical sharps are occasionally found in public areas such as public beaches, parks, and children's play areas.
• New devices, procedures, systems, and methods are needed for guarding, dispensing, and collecting contaminated sharps to minimize the risk of accidental wounding of healthcare workers and others by infectious, sharp devices. Such devices and procedures are particularly important in any medical setting including in-hospital, pre-hospital, outpatient, military, and the emergency department.
SUMMARY OF THE INVENTIONS
• This invention relates to devices to minimize the risk of infectious disease spread from one individual to another due to puncture wounds made by sharp, contaminated objects.
• An embodiment of the invention is a guard for sharps, or a sharp guard. Another embodiment of the invention is an integrated receiver and container assembly for point-of-use medical sharps containment and disposal. In one embodiment, a solid sheet of material is bi-folded to irreversibly, seal, blunt, sequester, entrap, or render useless, medical sharps. The bi-folded sharp guard structure includes optional tabs for grasping and removal from storage as well as optional tabs that may be folded over and adhered to further secure the entrapped medical sharp. The folding tabs may further comprise incomplete labeling that becomes complete when the tabs are folded over the sequestered sharp. The complete labeling indicates the presence of an entrapped contaminated medical sharp object. In an embodiment, the sharp guard is a single use, disposable device, which is not intended to be reprocessed by cleaning, disinfection, sterilization, or the like.
• In an embodiment, the sharp guard can be used at the point-of-use to protect or sequester sharp medical devices. The sharp guard may be used for most of the sharps commonly encountered in hospital, lab, ambulance, or office practice. These sharps include scalpel blades, hypodermic needles with or without an attached syringe barrel, trocars, cannulae, and the like. The sharp guard includes protection of the healthcare worker from the moment subsequent to use of a medical sharp on a patient until the point where it is physically placed in the disposal receptacle. Additionally, the sharp guard can be implemented economically using techniques such as thermoforming, injection molding, die stamping, and the like.
• In one embodiment of the invention, an apparatus adapted for entrapment of medical sharps comprises a shell having an upper portion and a lower portion, an expandable hinge which connects the upper portion to the lower portion, and a pad affixed to the inside surface of the lower portion. The pad comprises an adhesive layer, and a gap-filling deformable layer disposed between the adhesive layer and the inside surface of the lower portion where a medical sharp set on the adhesive layer is trapped between the upper portion and the lower portion when the shell is closed.
• In another embodiment, the apparatus adapted for entrapment of medical sharps also comprises another pad affixed to the inside surface of the upper portion. In another embodiment, a pad for entrapment of a medical sharp comprises an adhesive layer; and a gap-filling deformable layer disposed below the adhesive layer, where the gap-filling deformable layer substantially deforms to the contour of the medical sharp to fill substantially all gaps around the contour of the medical sharp when the medical sharp is pressed into the adhesive layer.
• In another embodiment, a method of disposal for a used medical sharp comprises providing an open disposable sharps containment device at a point-of-use of a medical sharp, and placing the medical sharp onto the sharps containment device at the point-of-use, where the medical sharp comprises a sharp portion and a blunt portion. The method further comprises closing the sharps containment device at the point-of-use, where the sharp portion is embedded within the containment device, and the blunt portion protrudes from the closed containment device. The method further comprises transporting the containment device including the embedded medical sharp to a medical waste disposal container remotely located from the point-of-use of the medical sharp.
• In a further embodiment, an apparatus adapted for entrapment of medical sharps comprises a dispenser at the point-of-use of the medical sharp, where the dispenser contains a plurality of medical sharp containment devices. Each medical sharp containment device comprises a bi-folded puncture resistant shell; and at least one adhesive pad attached to the inside of the shell. The dispenser presents the medical sharp containment device to a user for placement of a used medical sharp therein, and the dispenser presents another medical sharp containment device only upon removal of the first medical sharp containment device.
• Another embodiment of the invention is a system comprising a sharp guard, a distributed sharp guard dispenser for dispensing unused sharp guards, and a sharp guard receptacle for receiving sharp guards containing a sharp.
• In an embodiment, a sharp guard can be obtained from one of numerous dispensers affixed to walls or counter surfaces. The sharp guard, in another embodiment, is obtained from a transportable kit and is dispensed at the point of use. The dispensers work either manually or automatically. The sharp guard is used to safely render the sharp object unable to puncture another individual. Finally, in an embodiment, the protected sharps and sharp guard are discarded into a specially designed sharps receptacle. The sharp guard, in another embodiment, is included in prepackaged sterile surgical, suture, or procedure kits. Both the dispenser and the receptacle include optional visual monitoring, through windows or other indicators, so that the contents and fill level can be determined easily. The receptacle further includes a closure or seal for final disposal.
• The sharp guard is comprised of a sheet or sheets of material that are capable of embedding, entrapping, folding over, sequestering, and otherwise rendering the sharp object harmless, unusable, and blunt. The sharp guard is, in an embodiment, a sheet of bi-folded material such as, but not limited to, cardboard, polystyrene, foamed polymer, or the like, that is folded in half over the sharp object and sealed permanently so that the sharp object cannot be removed, exposed, or otherwise used. The sharp guard includes, in an embodiment, tabs that close over the bi-folded sheet and lock or adhere to complete the closure. Labeling affixed to the surface of the sharp guard indicates when the sharp guard is undeployed, and when it is in its deployed and sealed state with biological waste entrapped therein.
• In another embodiment, the sharp guard system comprises a bi-folded sheet of protective material that is presented to the medical caregiver by its dispenser. When one sharp guard is used and removed from the dispenser, another sharp guard, automatically or under manual control, is positioned for use in protecting another sharp. The medical caregiver places the contaminated sharp against the protective sheet of material and presses the sharp into the folded opening of the sharp guard and against the fold. The dispenser causes the protective cover to fold over the sharp under the influence of downward, manual pressure and coercion from side compression members on the dispenser. The protective cover finally closes and irreversibly seals over the sharp. The disabled sharp and its protective cover are removed from the dispenser and placed in a receptacle. Another sharp protective cover moves into place for ready to receive another sharp.
• Materials for the protective cover for the sharp guard include, but are not limited to, foamed polymers, cardboard, polymer sheets, and the like. The internal surfaces of the sharp protective cover are preferably fabricated from adhesive materials that entrap and grab the sharp and cause the closed sharp protective cover to remain sealed over the sharp. Active foaming materials are also desirable so that the presence of the metal sharp or any liquids causes a catalytic reaction that actively foams the side of the protective cover toward the sharp and encases the sharp in foam which seals to the other side of the bi-folded protective cover or simply seals the sharp. In yet another embodiment of the invention, the fold of the bi-folded protective sheet comprises multiple creases to accommodate sharp devices of various thicknesses. Such multiple creases may comprise, for example, an accordion, “U”, “Z”, “V”, or “W” shaped configuration.
• In a preferred embodiment, the same device is used for dispensing and disposal of the Sharp Guard, and is easily and quickly replaced when empty of new, unused product or full of used product. A user has a visual indication that the receptacle is full and that no additional sharps can be added to the receptacle. The system is foolproof and clear even to an untrained user that no additional sharps, even protected sharps, can be added. The receptacle is designed so that users can easily tell when it is full so they will not inadvertently cut themselves trying to stuff an already full container with yet another sharp. In yet another embodiment, the receptacle opening is rendered closed when it has been loaded with enough protected sharps to fill it. The sharp guard system is, preferably, a completely disposable system and is an acceptable end-receptacle for medical sharps that can be placed directly into the medical waste system without requiring an intermediate sharps container as is required by most current systems and devices. The protective covers are disposable, the dispenser is disposable, and the receptacle is disposable. All items are fabricated from materials that may be incinerated in the medical waste system.
• Both the dispenser and the receptacle are preferably configured to permit access to a sharp guard with only one hand and further, to dispose of a sharp guard and entrapped sharp with only one hand. The one-handed functionality is, preferably, achieved by opening the dispenser or receptacle with only one hand and then placing the sharp guard within the receptacle, again with one hand only. This one-handed functionality relies on dispenser and receptacle opening systems that store energy and use the stored energy to open the dispenser or receptacle lid using hand or finger pressure. If the user prefers, two-handed operation is equally safe and effective.
• In yet another embodiment of the sharp guard system, a healthcare provider may carry around a portable encapsulator. The portable encapsulator may be hooked to the belt, placed in a pocket, hung around the neck, etc., of the healthcare provider. The portable encapsulator comprises an openable shell, a reservoir of encapsulation material, an activation mechanism, and a hardening system. In this embodiment, the lid of the shell is opened, the sharp is placed into the shell and the lid is closed. Encapsulation material flows around the sharp and into a pre-configured mold area. The encapsulation material is then hardened to form a rigid blunt barrier around the sharp. The encapsulation system comprises material such as, but not limited to, ultra-violet (UV) curable adhesives such as those made from polyurethane, two-part epoxies, hardening foams, gels, and the like. The hardening system comprises, for example, an ultraviolet light that activates hardening of the UV curable adhesive. The key feature of this and other embodiments is that the sharp guard is available at the point-of-use.
• Because the sharp guard is simple to use, there is minimal training involved and very low risk of error that could cause inadvertent injury. Its design makes it very difficult to use it incorrectly, and its correct use minimizes the risk of injury to healthcare workers. By product design, contaminated sharps are directed away from potential contact with users until the sharp is enclosed in the device. Once enclosed, accidental contact with the sharp is virtually impossible during normal use and activity. Hospital and healthcare workers can be trained and policies can be set to ensure that all workers are fully aware of the procedures necessary to make the sharp guard system functional. The implementation cost of the sharp guard system is minimal and the time to train is less than 30 minutes per trainee and, preferably, less than 10-15 minutes per trainee.
• The policy to use the sharp guard comprises making the policy available on a proactive basis to all primary and ancillary personnel involved with sharps. The policy emphasizes the need to keep sharp guard systems near the point of use, including available in or around the sterile or operative field. The policy further requires that all sharps are encased or protected within a sharp guard prior to placing them in a sharps receptacle, or directly into the hospital medical waste system without an intermediate sharps receptacle. The policy preferably comprises the step of not moving your feet, as a sharps user, between when the sharp is used and when it is encased or entrapped within a sharp guard. The policy further requires that the medical sharp be encapsulated prior to turning or rotating the body when a used medical sharp is in a user's hand. Reinforcement of the policy will be an ongoing effort. The policy further comprises steps to ensure that sharp guard dispensers are maintained with unused sharp guards always available and that sharp guard receptacles never become completely full before they are emptied or disposed of. In addition, a label is preferably provided on the receptacle that indicates that the receptacle is for placement of sharp guard protected sharps only.
• The sharps disposal system, in certain embodiments, can comprise a puncture resistant barrier, a fluid tight seal, an adhesive to prevent dislodgement of a used medical sharp, and a non re-openable locking system to prevent the system from being re-opened. The sharps disposal system advantageously comprises a low-cost liner that serves as an enhanced puncture barrier. The foam is capable of absorbing liquids and of sealing the perimeter of the sharp disposal system in its closed configuration. As such, the sharps disposal system is portable and available at the point of use in the medical environment, but meets all requirements for final disposal of medical sharps so that use of a secondary, sharps disposal container is not required prior to placement of the entrapped medical sharp within the red biohazard bag within the medical facility. These requirements include stability, durability, resistance to puncture, resistance to impact, resistance to leakage of contaminated biological fluids and tissues during use, handling, storage, and transportation. The sharps disposal is convenient and accessible to medical caregivers and to those who use, maintain, and dispose of medical sharp devices. Furthermore the system can comprise a closure device design to minimize exposure to sharps during activation and designed to resist manual opening once sharps are enclosed therein. The sharps disposal container can comprise a receiving pad further including one or more needle re-capping feature, a sharp safety zone, and a suture needle collection and counting area. The entire system is configured for assembly line manufacturing at very low cost to enable its use on a widespread basis in a wide variety of medical venues.
• In an embodiment, when a specific medical sharp has been identified as suitable for point-of-use disposal, a sharp guard can be functionally and physically tailored for this application. The sharp guard is preferably configured or fabricated to hold the sharp securely, and entirely entrapped, for disposal. The embodiment may use all of some of the typical sharp guard features of protective exterior shell, absorbent foam, mat liners, adhesives and clasp and interlock closures. The sharp may be pre-packaged in the sharp guard and when used, disposed of in the same container. This provides all of the advantages discussed elsewhere of the sharp guard disposal system. Sharp guard applications include supporting many outpatient or home health care recurring injections.
• In other embodiments, the Sharp guard can comprise permanent or temporary adhesives, clamps, or high-friction materials or structures on its bottom surface to resist sliding relative to a surface on which it rests. It is beneficial that the Sharp guard not slide or easily move around relative to the surface on which it rests so that a user can insert contaminated medical sharps with one hand and the Sharp guard does not slide or move inappropriately under the manually applied forces. Such adhesives can comprise partially or fully cross-linked adhesives, hook and loop fasteners, double-sided adhesive tape, clips, clamps, buttons, snaps, or the like.
• In other embodiments, the Sharp guard can comprise a strap, belt, or other closure capable of being wrapped around protruding blunt ends of entrapped sharps such that the medical sharp is fully prevented from backing out of an opening in the Sharp guard. The strap, belt, or other closure can be affixed to the bottom of the shell and be selectively affixed to the top of the shell using irreversible or reversible fasteners.
• In other embodiments, the Sharp guard can comprise labeled regions on one of the internal foam pads or adhesive layers that indicate appropriate areas in which to insert the pointed part of the medical sharp so that removal forces of the medical sharp exceed specified values.
• In some embodiments, the Sharp guard can be used to entrap, sequester, embed, hold, or otherwise convey a used, contaminated medical sharp from the point of use directly into the biohazard disposal bag commonly found in medical facilities. In these embodiments, the wall-mounted hard, sharps disposal containers are not required for intermediate placement of the contaminated medical sharps prior to disposal in the biohazard waste. The biohazard waste, or biohazard trash, is generally a polymeric bag and is generally colored red to signify the presence of a hospital biohazard. This biohazard bag is often termed the “red bag”. Typically, biohazard waste is disposed in an incinerator.
• In other embodiments, the Sharp guard can comprise internal high-friction materials to minimize the risk of the entrapped medical sharp moving once placed therein. Such high-friction materials can comprise top or bottom foam pads or other structures exposed therein.
• In certain embodiments, the Sharp guard can comprise a needle removal mechanism. A hypodermic needle, attached to a syringe barrel by, for example, a Luer lock mechanism, can be inserted into the needle removal mechanism and then be safely removed from the syringe barrel by the user without risking injury. The needle removal mechanism can comprise a rigid bulkhead or rib, affixed within the Sharp guard such that a syringe needle can be inserted into a hole or a slot, gripped by the hole or slot such that the needle cannot rotate, and then removed from the syringe barrel by rotating the syringe barrel to disengage the Luer mechanism connecting the syringe barrel to the Luer lock syringe. Beneficial features are that the bulkhead or rib be substantially rigid and firmly affixed to the Sharp guard either on the interior (preferred) or the exterior. The hole or slot is beneficially visible to the user for precise alignment and engagement of the needle. The hole or slot can, in some embodiments, comprise a lead-in, funnel, or tapered entry path to guide or direct the sharp needle into the hole or slot to minimize difficulties in performing this procedure. The needle removal mechanism, in some embodiments, can be located generally in a central region of the Sharp guard interior. Access to the slot or hole in the needle removal mechanism can be facilitated by reducing the height of foam in front of the needle removal mechanism such that visibility of the slot or hole is optimized. The foam in this region can be reduced in height or lower. Foam in the top region of the Sharp guard can be formed in a complementary configuration such that it projects into any uneven or irregular areas of the lower foam, such as foam removed to expose the needle removal mechanism.
• In other embodiments, the Sharp guard can be configured with a first internal volume that is sealed against fluid leakage, and a second internal volume that retains protruding blunt ends of medical sharps but does not prevent fluid leakage. A needle removal mechanism can be comprised or affixed to the interface between the sealed and non-sealed internal regions.
• In other embodiments, the Sharp guard can comprise a scalpel removal mechanism affixed to the Sharp guard in the same, or similar, fashion as the needle removal mechanism.
• In other embodiments, the Sharp guard system can be built into a sterile procedure tray. The Sharp guard can be affixed to the tray or it can be fabricated integral to the tray, itself.
• For purposes of summarizing the invention, certain aspects, advantages and novel features of the invention are described herein. It is to be understood that not necessarily all such advantages may be achieved in accordance with any particular embodiment of the invention. Thus, for example, those skilled in the art will recognize that the invention may be embodied or carried out in a manner that achieves one advantage or group of advantages as taught herein without necessarily achieving other advantages as may be taught or suggested herein.
• These and other objects and advantages of the present invention will be more apparent from the following description taken in conjunction with the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
• A general architecture that implements the various features of the invention will now be described with reference to the drawings. The drawings and the associated descriptions are provided to illustrate embodiments of the invention and not to limit the scope of the invention. Throughout the drawings, reference numbers are re-used to indicate correspondence between referenced elements.
• FIG. 1A illustrates an oblique view of a flat, un-deployed sharp guard, according to an embodiment of the invention;
• FIG. 1B illustrates an oblique view of the sharp guard in its open, deployed state, according to an embodiment of the invention;
• FIG. 1C illustrates an oblique view of the sharp guard in the closed state with a hypodermic needle trapped therein, according to an embodiment of the invention;
• FIG. 2A illustrates a top view of the sharp guard in its undeployed flat configuration, according to another embodiment of the invention;
• FIG. 2B illustrates a side cutaway view of a folded sharp guard showing additional details of an entrapment pad, according to an embodiment of the invention;
• FIG. 3 illustrates an oblique view of a stack or plurality of un-deployed, flat sharp guards, according to an embodiment of the invention;
• FIG. 4A illustrates an oblique view of a sharp guard dispenser with a plurality of un-deployed sharp guards loaded therein, according to an embodiment of the invention;
• FIG. 4B illustrates an oblique cut away view of the sharp guard dispenser filled with a plurality of un-deployed sharp guards, according to an embodiment of the invention;
• FIG. 4C illustrates an oblique view of the sharp guard dispenser with a sharp guard being removed, according to an embodiment of the invention;
• FIG. 5 illustrates an oblique view of another embodiment of a dispenser for sharp guards comprising a single central opening on the top of the dispenser and a one-hand operated spring-loaded lid;
• FIG. 6A illustrates an oblique view of a sharp guard dispenser attached to the rail of a hospital bed, according to an embodiment of the invention;
• FIG. 6B illustrates an oblique view of the sharp guard dispenser attached to a bed stand, according to an embodiment of the invention;
• FIG. 7A illustrates an oblique view of the sharp guard receptacle with a sharp guard being inserted, according to an embodiment of the invention;
• FIG. 7B illustrates an oblique view of the sharp guard receptacle, which has become full and can no longer accept new sharp guards, according to an embodiment of the invention;
• FIG. 8 illustrates an oblique view of another embodiment of a receptacle for sharp guards comprising a single opening and a single area to hold the sharps, according to an embodiment of the invention;
• FIG. 9A illustrates a sharp guard delivery system, according to an embodiment of the invention;
• FIG. 9B illustrates another embodiment of a sharp guard delivery system comprising a bracket to hold the dispenser and the receptacle, according to an embodiment of the invention;
• FIG. 10 illustrates an embodiment of the sharp guard in its sterile package, according to an embodiment of the invention;
• FIG. 11A illustrates a top view of an embodiment of the sharp guard removed from its sterile package in its unfolded configuration, according to an embodiment of the invention;
• FIG. 11B illustrates a side end view of the open sharp guard ofFIG. 11A, according to an embodiment of the invention;
• FIG. 11C illustrates an oblique view of the open sharp guard ofFIG. 11A, according to an embodiment of the invention;
• FIG. 12A illustrates a top view of an embodiment of the sharp guard ofFIG. 11A following closure, according to an embodiment of the invention;
• FIG. 12B illustrates an end view of an embodiment of the sharp guard ofFIG. 11B following closure, according to an embodiment of the invention;
• FIG. 12C illustrates an oblique view of an embodiment of the sharp guard ofFIG. 11C following closure, according to an embodiment of the invention;
• FIG. 13A illustrates an embodiment of a sharp guard foam insert label, according to an embodiment of the invention;
• FIG. 13B illustrates an embodiment of a sharp guard further comprising a needle re-capping station being used to re-cap a syringe needle, according to an embodiment of the invention;
• FIG. 14A illustrates an embodiment of the sharp guard wherein the sharp guard forms part of the initial packaging of a dedicated medical sharp, according to an embodiment of the invention;
• FIG. 14B illustrates an embodiment of the sharp guard following closure around a used, dedicated medical sharp, according to an embodiment of the invention;
• FIG. 15 illustrates a cross-sectional view of a sharp guard further comprising an absorbent pad and a seal gasket around the perimeter, according to an embodiment of the invention; and
• FIG. 16 illustrates an oblique view of a sharp guard comprising a first sealed space or volume, a second, unsealed space or volume, and a sharp removal mechanism affixed at an intermediate region between the first sealed volume and the second, unsealed volume, according to an embodiment of the invention.
DETAILED DESCRIPTION OF THE INVENTIONS
• In accordance with one or more embodiments of the present invention, a plurality of embodiments of a sharp guard system is described herein. In order to fully specify this preferred design, various embodiment specific details are set forth, such as the shape and size of the receptacle as well as the dispenser. It should be understood, however that these details are provided only to illustrate the presented embodiments, and are not intended to limit the scope of the present invention.
• FIG. 1A illustrates an oblique view of an embodiment of asharp guard10 in the fully open or flat configuration. Thesharp guard10 comprises anupper support12, ahinge area14, alower support16, a plurality ofoptional folding tabs18, and a pull-tab20. Theupper support12, thehinge area14, thelower support16, theoptional folding tabs18 and the pull-tab20 of thesharp guard10 are permanently affixed to each other and are, preferably, fabricated from the same piece of material in a unitary structure. In some embodiments, thehinge area14 is pre-defined and located at a specific location on thelower support16, theupper support12, or both.
• In an embodiment, theupper support12, thehinge area14, thelower support16, theoptional folding tabs18 and the pull-tab20 are fabricated from puncture resistant thermoplastic materials including, but not limited to, polyethylene terephthalate, polystyrene, polyethylene, polypropylene, or the like. In another embodiment, other puncture resistant materials, including, but not limited to, cardboard, paper, polyurethane foam, polyvinyl chloride foam, cork, synthetic composites, polyester, and the like, may be used. Because of its minimal cost and easy manufacturability, polystyrene sheet is the preferred material for fabrication of theupper support12 and thelower support16, including anytabs18.
• In another embodiment, theupper support12, thehinge area14, thelower support16, theoptional folding tabs18 and the pull-tab20 are laminated with puncture resistant materials, such as ceramics, metals, or polymers. Exemplary laminate materials include, but are not limited to, low density polyethylene, polyester, polyimide, polyamides, stainless steel, stainless steel mesh, Kevlar®, aluminum, and the like.
• Fabrication processes forupper support12, thehinge area14, thelower support16, theoptional folding tabs18 and the pull-tab20 include, but are not limited to, extrusion, injection molding, insert molding, thermoforming, and the like.
• Thesharp guard10 further comprises an upperadhesive region24 and a loweradhesive region26. The upper and loweradhesive regions24 and26, respectively, are permanently adhered to theupper support12 and thelower support16 and comprise an embedding adhesive material. The upperadhesive region24 and the loweradhesive region26 are configured to permanently and irreversibly bond to each other and entrap or sequester the sharp therein when thesharp guard10 is folded closed over a sharp. Further, the embedding adhesive of the upperadhesive region24 and the loweradhesive region26 not only sticks to itself and an entrapped sharp, but deforms and completely conforms to and surrounds the sharp. The adhesive is malleable and deforms to surround and fill any gaps or spaces that may be created around a large diameter sharp. Theadhesive regions24 and26 preferably do not extend into thehinge area14. The gap-filling nature maximizes adhesive contact surface area on the sharp and seals the sharp to prevent fluid leakage or spillage.
• In an embodiment, the upperadhesive region24 and the loweradhesive region26 are thick and flowably or malleably deformable. Thus, when a thick sharp is enclosed within thesharp guard10, theadhesive regions24 and26 flow aside and permit full entrapment of the large sharp with no air gaps extending to the exterior of theupper support12 orlower support16.
• Further, such prevention or minimization of air gaps will prevent smaller sharps that are placed within thesharp guard10 from inadvertently falling out through the air gap route to the exterior of thesharp guard10.
• The upperadhesive region24 and the loweradhesive region26 are fabricated from adhesives that permanently adhere to theupper support12 and thelower support16, respectively. Examples of the embedding adhesive utilize or comprise base materials of acrylics, acrylate polymers, polychloroprenes, cyanoacrylates, and the like. In an embodiment, the upperadhesive region24 and the loweradhesive region26 are approximately 0.01 inch to approximately 2.0 inches thick, and preferably 0.1 inch to approximately 0.5 inch thick.
• In another embodiment, the embedding adhesive is laminated onto foam, which is preferably malleably deformable to accommodate sharps of varying size and thickness. This is to enhance bond strength, which is dependent upon the amount of adhesive-to-surface contact developed. Examples of the foam are closed cell polyvinyl chloride foam (vinyls), styrene block copolymer (SBC), polyurethane, polyester, open cell polyvinyl chloride foam (vinyls), styrene block copolymer (SBC), and the like. In an embodiment, the foam is approximately 0.1 inch to approximately 2.0 inches thick, and preferably 0.25 inch to approximately 1.5 inches thick.
• In another embodiment, the embedding adhesive is laminated onto a gel, which is preferably malleably deformable to accommodate sharps of varying size and thickness. Examples of the gel are sealant type materials utilizing a base material of epoxy, acrylic, nitrile, hydrophilic hydrogel, collagen, and the like. In an embodiment, the gel is approximately 0.1 inch to approximately 2.0 inches thick, and preferably 0.25 inch to approximately 1.5 inches thick.
• In yet another embodiment, the adhesive, gel or foam is affixed only at or near the exterior of thesharp guard10 to prevent exit routes for the sharps while maintaining a lower overall device cost.
• In another embodiment, the upperadhesive region24 and the loweradhesive region26 comprise an absorbent material, such as, but not limited to, carboxymethyl cellulose, cotton, paper, sea sponge, hydrophilic hydrogel, wood cellulose fiber, cellulose-based fiber granules, absorbent polyacrylate, wood pulp/polypropylene/cellulose, wood pulp and other fiber blends with polypropylene, polyester and polyethylene, and the like. In addition, specialized absorbent and foaming materials such as, but not limited to, encapsulated monosodium citrate and an alkali metal or alkaline earth metal salt thereof could also be utilized. Specific applications may contain any combination of components such as carboxy-methyl cellulose, polypropylene, non-woven polyethylene film laminate, cellulose/polyester, non-woven polyester microfiber, polyethylene coated film or paper and polyester packing pouches.
• Thesharp guard10 further comprises anadhesive cover strip28 on the exposed surface of theadhesive regions24 and26. Theadhesive cover strip28 further comprises an adhesive cover strip pull-tab34. Theadhesive cover strip28 and its integral adhesive cover strip pull-tab34 cover theadhesive regions24 and26 until such time as theadhesive cover strip28 is removed and thesharp guard10 is ready for a medical sharp object to be adhered and sandwiched between the upperadhesive region24 and the loweradhesive region26. The adhesive cover strip pull-tab34 is designed to facilitate easy grasping by the user and enables the user to lift theadhesive cover strip28 to fully uncover theadhesive regions24 and26. It is preferable that theadhesive cover strip28 be removed from both the upperadhesive region24 and the loweradhesive region26 using a single motion on the part of the user. Thus, in an embodiment, a single pull-tab34 controls the cover strips28 over both theupper adhesive24 and thelower adhesive26.
• Theadhesive cover strip28 and the adhesive cover strip pull-tab34 are preferably a unitary structure and comprise materials that do not adhere to the upperadhesive region24 and the loweradhesive region26. Such materials depend on the nature of the embedding adhesive material used in the upperadhesive region24 and the loweradhesive region26. In an embodiment, polytetrafluoroethylene, other fluoropolymers, metal foils, and the like, are suitable materials for theadhesive cover strip28 and the adhesive cover strip pull-tab34.
• The pull-tab20 is designed to facilitate easy grasping of thesharp guard10 by the user and enables the user to remove thesharp guard10 from a sharp guard dispenser.
• The flat configuration illustrated inFIG. 1A is the configuration in which thesharp guard10 is manufactured and most compactly stored prior to use. The sharp guard is sized so that it can encapsulate the majority of medical sharps. In an embodiment, the length of thesharp guard10 from theupper support12 to thetab20 is between approximately 0.5 inch and approximately 10 inches, preferably is between approximately 2 inches and approximately 7 inches and most preferably is between approximately 3 inches and approximately 5 inches. In an embodiment, the width of thesharp guard10 from an outside edge of onetab18 to an outside edge of anopposite tab18 is between approximately 0.5 inch and approximately 10 inches, preferably is between approximately 2 inches and approximately 7 inches and most preferably is between approximately 3 inches and approximately 5 inches.
• FIG. 1B illustrates an oblique view of an embodiment of thesharp guard10 in a partially folded and partially open configuration. Thesharp guard10 comprises theupper support12, thehinge area14, thelower support16,optional folding tabs18, and the pull-tab20.
• In an embodiment, thehinge area14 is integrated with theupper support12 and thelower support14, and is height adjustable. Thehinge area14 is height adjustable to permit thesharp guard10 to accommodate sharps of varying thickness. Typically, a medical sharp comprises a sharp portion connected to a blunt portion. Sharp portions are, for example, needles, scalpel blades, trocars, tubes, wires and other medical procedure devices, objects or instruments, which can penetrate the skin, and the like. Blunt portions are, for example, handles, syringe bodies, tubing, connectors, catheters, specialized containers, and the like. Typically, once used, the entire medical sharp is thrown away.
• Thehinge area14 is preferably fabricated by creating creases or thin areas in theupper support12 and thelower support14, which are, preferably, fabricated from the same piece of material. In an embodiment, thehinge area14 comprises a complex hinge or multiple hinges. In an embodiment, thehinge area14 comprises a single crease or region of material thinness. In another embodiment, thehinge area14 is a doubly creased area forming a “U” shape or a book hinge. In a further embodiment, thehinge area14 is a “W” folded or tri-folded configuration capable of expanding substantially. In another embodiment, thehinge area14 is an accordion fold or z-fold that comprises a plurality of hinges to allow thehinge area14 to expand substantially or compress substantially. Since the thickness of a sharp to be embedded is variable, thehinge14 accommodates a wide range of thicknesses and still allows theupper support12 and thelower support16 to be substantially parallel to each other when thesharp guard10 is closed around the sharp. The accordion fold or other multiply creasedhinge14 provides for such parallelism in the closure of theupper support12 and thelower support16.
• In an embodiment, the thickness of the folded,unexpanded hinge area14 is between approximately 0.1 inch and 0.25 inch. When expanded, thehinge14 is between approximately 0.1 inch and 2 inches, and preferably is between 0.25 inch and 1.5 inches.
• FIG. 1C illustrates an oblique view of an embodiment of thesharp guard10 in a closed configuration with a sharpmedical object30 embedded therein. Typically, a healthcare worker places the used medical sharp30 into the loweradhesive region26 and folds theupper support12 over thelower support16. The upperadhesive region24 and the loweradhesive region26 adhere together, embedding the sharp30. Theupper support12, thehinge area14, and thelower support16 form a puncture resistant shell or case around the embedded sharp30.
• In an embodiment, the health care worker can also fold theoptional tabs18 over theupper support12 to provide additional sealing of thesharp guard10.
• In an embodiment, theoptional tabs18 comprise snaps or locks to provide audible and tactile feedback that thesharp guard10 is closed around the sharp. The snaps or locks preferably irreversibly lock thesharp guard10 closed. These locks may be molded into the structure and comprise tapers that facilitate intermeshing of thesharp guard10 surfaces and overhangs or catches that prevent disengagement of the lockedsharp guard10.
• Thus, thesharp guard10 protects the healthcare worker from needlesticks, punctures, and cuts caused by the contaminated sharp30. Thesharp guard10 is applied to the contaminated sharp30 at the point of use, which may, in an embodiment, generally be described as a location wherein the user does not have to move their feet or turn to apply thesharp guard10 to the contaminated sharp30.
• Thesharp guard10 further comprises alabel22. Thelabel22 preferably comprises a standard biohazard symbol and a notation that the contents may be pathogenic or contaminated with medical waste. In one embodiment, thelabel22 is affixed to the outer surface of theupper support12. In yet another embodiment, thelabel22 affixed to the underside of the plurality ofoptional folding tabs18 so that when the tabs are folded over theupper support12, their edges are adjacent and a complete statement is legible. When thetabs18 are open, the part of thelabel22 on eachtab18 is incomplete and does not display a coherent message. In an embodiment, the loweradhesive area26 extends onto the upper surfaces of thetabs18 and serves as a permanent and irreversible closure for thetabs18 when they are folded over the outside of theupper support12.
• Thesharp guard10, in another embodiment, further comprises anadhesive catalyst32. In an embodiment, theadhesive catalyst32 is located on the outer surface proximate to thehinge area14. In another embodiment, theadhesive catalyst32 is proximate to and over thehinge area14. Theadhesive catalyst32 promotes adhesion between the employedsharp guard10 and a sharp guard receptacle when the employedsharp guard10 is placed in the sharp guard receptacle.
• FIG. 2A illustrates another embodiment of thesharp guard10. Thesharp guard10 comprises theupper support12, thehinge area14, and thelower support16. Theupper support12 further comprises a plurality ofprotrusions106, and aflat area108 having an optional raised stiffeningrim110. The raisedrim110 is slightly raised to maximize structural stiffness and rigidity. Thelower support16 further comprises a plurality ofcircular depressions104, and a raisedarea100 having anoptional recess102.
• Theprotrusions106 and the raisedstiffening rim110 on theupper support12 are aligned with thecircular depressions104 and therecess102 on thelower support16 such that when thesharp guard10 is folded over the sharp30, theprotrusions106 and the raisedstiffening rim110 fit snugly within and intermesh with thecircular depressions104 and therecess102, respectively. In an embodiment, theprotrusions106 latch into thedepressions104 when thesharp guard10 is closed. In an embodiment, the protrusions irreversibly106 latch into thedepressions104 when thesharp guard10 is closed.
• In another embodiment, theflat area108 comprises slots, wells, or cutouts that accept the raisedarea100 and permit the raisedarea100 to project beyond the plane of theflat area108 of the bi-folded surfaces.
• Thesharp guard10 further comprises the upperadhesive region24 and the loweradhesive region26. The upperadhesive region24 is level with theflat area108. The loweradhesive region26 sets in a depression surrounded by the raisedarea100. In an embodiment, the upperadhesive region12 and the loweradhesive region16 comprise an embedding adhesive material such as polyurethane-based adhesives, acrylics, acrylate polymers, polychoroprenes, cyanoacrylates, and the like. The loweradhesive region26 optionally comprises holes, openings, orfenestrations158 which permit diffusion or absorption of fluid from the embedded sharp30 into a region separated from the sharp30 by the loweradhesive region26.
• In an embodiment, the loweradhesive region26 further comprises an absorbent spun material, such as, for example compounds of methyl cellulose, cotton, paper, polyester, polypropylene non-woven/polyethylene film laminate, cellulose/polyester, non-woven polyester microfiber, polyethylene coated film or paper, polyester packing pouches, and the like, under the embedding adhesive material. In another embodiment, the spun material comprises absorbent additives, such as, for example, carboxymethyl cellulose, hydrophilic hydrogel, sea sponge, wood cellulose fiber, cellulosic-based fiber granules, absorbent polyacrylate, wood pulp/polypropylene/cellulose, wood pulp and other fiber blends with polypropylene, polyester and polyethylene, and the like. In addition, special absorbent materials may be added such as, but not limited to, encapsulated monosodium citrate and an alkali metal or alkaline earth metal salt thereof and the like. In an embodiment, the upperadhesive region24 and the loweradhesive region26 further comprise the absorbent spun material.
• In yet another embodiment, the loweradhesive region26, further comprises a foaming material, such as, but not limited to, encapsulated monosodium citrate and an alkali metal or alkaline earth metal salt thereof, and the like, under the embedding adhesive material. The foaming material foams in the presence of the metal sharp30 or any liquids present with the used metal sharp30, to further contain the used sharp30. In another embodiment, the upperadhesive region24 and the loweradhesive region26 further comprise the foaming material.
• In yet another embodiment, the loweradhesive region26 further comprises a cover. The cover facilitates contact with the deformable and/or absorptive material of the upper and/or loweradhesive regions24,26. In an embodiment, the cover may be treated with an adhesive. In an embodiment, the cover material may be a fine denier woven or non-woven spinable polyester. In yet another embodiment, the upperadhesive region24 and the loweradhesive region26 further comprise the cover.
• In another embodiment, thesharp guard10 further comprises alower opening112. Thelower opening112 is located along an edge of thelower support16 at a break in the raisedarea100. The loweradhesive region26 extends into thelower opening112. The upperadhesive region24 extends into theflat area108. Thelower opening112 and the upperadhesive region24 which extends into theflat area108 are aligned such that the upperadhesive region24 which extends into theflat area108 sets over thelower opening112 when the user closes thesharp guard10.
• In another embodiment, the loweradhesive region26 comprises apad150.FIG. 2B illustrates a cross section of thesharp guard10 comprising thepad150. Thepad150 comprises anadhesive layer152 comprising materials such as acrylics, acrylate polymers, polychloroprenes, cyanoacrylates, and the like. Theadhesive layer152 adheres to the sharp30, the upperadhesive region24, and itself when thesharp guard10 is closed around the sharp30 to embed and entrap the sharp30 within thesharp guard10.
• In another embodiment thepad150 further comprises a gap-fillingdeformable layer154 disposed between theadhesive layer152 and an inside surface of thelower support16. Examples of a gap-filling deformable material include, but are not limited to hydrogel, soft foams of polyvinyl chloride, polyurethane, or polyester, closed cell polyvinyl chloride foams (vinyls), polystyrenes, styrene block copolymer (SBC), polyurethanes, polyesters, or the like. The gap-fillingdeformable layer154 deforms when the sharp30 is embedded or pressed into thepad150 to substantially fill any gaps surrounding the sharp30. The deformation is either resilient or the result of irreversible crushing of the gap-filling material. This further containssharps30 of varying sizes and diameters within thesharp guard10 when thesharp guard10 is closed. The gap-fillingdeformable layer154 expands to fill an interior space of the closedsharp guard10 having the embedded sharp30 such that there are substantially no gaps in the closed, employedsharp guard10.
• In an embodiment, thepad150 further comprises anabsorbent layer156 disposed below theadhesive layer152, comprising materials such as, for example, wood cellulose fiber, cellulose-based fiber granules, absorbent polyacrylate, wood pulp/polypropylene/cellulose, wood pulp, or the like. In another embodiment, thepad150 comprises a composite, an integrally distributed, or an itemized absorbent material, such as, for example, particles of carboxymethyl cellulose suspended in open-celled polyurethane foam, air-laid paper, wood cellulose fiber, cellulose-based fiber granules, absorbent polyacrylate, wood pulp/polypropylene/cellulose, wood pulp and other fiber blends with polypropylene, polyester and polyethylene, or the like. Theabsorbent layer156 or the absorbent materials substantially absorb any fluids contained on and/or in the used sharp30 to prevent fluids from leaking from the closedsharp guard10. Theadhesive layer152, in an embodiment, is perforated or fenestrated withopenings158 to permit fluid flow or diffusion into the layers below.
• In another embodiment, the upperadhesive region24 comprises thepad150. In a further embodiment, the upperadhesive region24 and the loweradhesive region26 each comprise thepad150.
• In an embodiment, thesharp guard10 has a orientation edge or guide to assist the healthcare professional with proper alignment of a syringe body and other pharmaceutical injection or infusion devices into thesharp guard10. This ensures that needles, catheters and other elongated medical sharps are properly orientated for maximum containment with thesharp guard10.
• The raisedarea100 forms a raised ridge with respect to the loweradhesive region26 to prevent the sharp from inadvertently being poked out of the edge of thesharp guard10. The ridge or raised edge forms a material barrier to the sharp30 around much of the perimeter of the foldedsharp guard10. The ridge or raised edge preferably does not extend through thelower opening112 where the medical sharp30 is inserted and a handle or other blunt portion may project out of thesharp guard10. This is especially useful in the context of large syringes or scalpels. The intermeshing of the raisedrim110 andprotrusions106 with therecess102 and thedepressions104 provides a barrier against sharps penetration.
• Referring toFIG. 2A, thehinge area14 is preferably fabricated by creating creases or thin areas in theupper support12 and thelower support16, which are, preferably, fabricated from the same piece of material. In an embodiment, thehinge area14 is an accordion fold that comprises a plurality of hinges to allow thehinge area14 to expand substantially or compress substantially. Since the thickness of the sharp30 to be embedded is variable, thehinge14 accommodates a wide range of thicknesses and still allows theupper support12 and thelower support16 to be substantially parallel to each other when thesharp guard10 is closed around the sharp30. The accordion fold or other multiply creasedhinge area14 provides for such parallelism in the closure of theupper support12 and thelower support16.
• In an embodiment, the thickness of thehinge area14 is between approximately 0.1 inch and 0.25 inch. When expanded, the thickness of thehinge area14 is between approximately 0.1 inch and 2 inches, and preferably is between 0.25 inch and 1.5 inches.
• In another embodiment of thesharp guard10, a pouch fabricated from materials including, but not limited to, Tyvek®, polyethylene, polypropylene, or the like is heat sealed around thesharp guard10 and thesharp guard10 is sterilized using ethylene oxide, gamma irradiation, or the like. Thesharp guards10 are preferably separately bagged or pouched and irradiated for single use in a sterile environment. In an embodiment, the pouch is a typical heat-sealed chevron-style or other style pouch known in the art as aseptic packaging that may be opened and the sterilesharp guard10 contents spilled or dumped into the sterile field using aseptic procedure. By this method, thesharp guards10 may be deployed onto a sterile field for use when needed.
• In yet another embodiment, thesharp guards10 are double pouched in a manner known as double aseptic packaging. A double-pouched sharp guard is asterile safeguard10 pouched in a first sterile pouch, and then the pouchedsafe guard10 is pouched in a second sterile pouch.
• FIG. 3 illustrates an oblique view of astack36sharp guards10. In an embodiment, thestack36 comprises between 1 and 100sharp guards10. In another embodiment, thestack36 comprises between 5 and 50sharp guards10, and in yet another embodiment, thestack36 comprises between 10 and 30sharp guards10. In a further embodiment, thestack36 comprises more than 100sharp guards10. Thestack36 facilitates shipping, storage, and dispensing of the sharp guards10. Thesharp guards10 may be non-sterile or they may be bagged or pouched and sterile.
• FIG. 4A illustrates an oblique view of adispenser40 forsharp guards10. Thedispenser40 comprises acase42, amount44, awindow46, and anopening48. Thedispenser40 is loaded with a plurality ofsharp guards10.
• Themount44 is affixed to thecase42 and is used to removably affix thecase42 to another object such as a table, bed, wall, or the like. Thewindow46 is affixed to thecase42 and permits viewing of thesharp guards10 or other contents of thecase42. Theopening48 is a penetration through thecase42 and may be located on the front of thecase42, on the top of thecase42, or it may be positioned partially on the top and partially on the front of thecase42, as shown inFIG. 4A.
• In an embodiment, thecase42 of thedispenser40 is fabricated from materials such as, but not limited to, polyvinyl chloride, polyethylene, polypropylene, polyester terephthalate (PET), acrylonitrile butadiene styrene (ABS), polystyrene, copolymers of the aforementioned, metal, sealed wood, cardboard, or any other material suitable for a container. In an embodiment, the preferred material is PET, cardboard, or polystyrene because of the low manufacturing cost of these materials. Preferred manufacturing methods for thecase42 include, but are not limited to, lamination, blow molding, extrusion, injection molding, thermoforming, and the like.
• Themount44 comprises non-permanent adhesives, magnets, clips, clamps, or the like. Themount44 is configured to allow thecase42 to be mounted to a wall, tabletop, bed rail, or any other surface or structure commonly found in a hospital, ambulance, or other medical facility.
• FIG. 4B illustrates a cut-away image of an oblique view of thedispenser40. Thedispenser40 comprises a plurality ofsharp guards10. Referring toFIGS. 3 and 4B, thesharp guards10 are arranged in thestack36. Thesharp guards10 in thestack36 may be sterile and separately pouched or they may be non-sterile. In an embodiment, thesharp guards10 are labeled with full Food and Drug Administration (FDA), Occupational Safety and Health Administration (OSHA) and International Standards Organization (ISO) specified labeling to characterize the device and the sterile or non-sterile nature of the device.
• FIG. 4C illustrates an oblique view of thedispenser40 with thesharp guard10 being removed through theopening48. Thedispenser10 further comprises anoptional lid closure50. Thelid closure50 is hinged to thecase42 so that it may be opened and closed. Thelid closure50 further comprises an optional lock to hold thelid closure50 closed against thecase42. In an embodiment, thelid closure50 comprises a spring to bias thelid closure50 in the open position. The lock holding thelid closure50 closed comprises a release button that may be depressed with a single finger. Depressing the lock releases thelid closure50 and the spring causes thelid closure50 to open, thus thelid closure50 is operable with a single press of the hand or finger. The same hand may be used to remove thesharp guard10 from thedispenser40. Thelid closure50 may then be closed by a single hand or finger and the lock holds thelid closure50 closed.
• FIG. 5 illustrates another embodiment of thedispenser40 forsharp guards10 comprising thecase42, theopening48, thelid closure50, a latch or lock49, and the plurality of undeployedsharp guards10. In this embodiment, theopening48 is arrayed generally centrally on a top surface of thecase42. Thelid closure50 is preferably biased open by a spring. The spring may be a leaf spring, a coil spring, or any other type of spring. The latch or lock49 is operable by simple pressure with a single finger and depression of thelock49 causes thelid closure50 to open by stored force in the spring and permits access to the contents of thecase42. The latch or lock49 is, in an embodiment, a simple molded catch or protrusion that engages with a feature on thecase42 and prevents thelid closure50 from opening. Depression of the latch or lock49 causes the catch or protrusion to become disengaged with thecase42 and allows the spring to move thelid closure50 to the open position. Thelid closure50 may then be closed with a single hand and the latch or lock49 engages with thecase42 when thelid closure50 is pushed closed. The stored force to open thelid closure50 may be generated by methods such as, but not limited to, a spring, a magnet, a motor, hydraulic or pneumatic pressure, and the like.
• In an embodiment, thedispenser40 presents the user with the opensharp guard10. The medical caregiver places the contaminated sharp30 against the loweradhesive region26 and presses the sharp30 against the fold or hingearea14. Thedispenser40 causes the protective covers of the upper andlower supports12,14 to fold over the sharp30 under the influence of downward manual pressure and coercion from side compression members on thedispenser40. Thesharp guard10 finally closes and irreversibly seals over the sharp30. The disabled sharp30 and its protective cover orsharp guard10 are removed from thedispenser40 and placed in a receptacle. Anothersharp guard10 moves into place to contain another sharp30. In another embodiment, the closing action for thesharp guard10 may be derived from an active source such as a motor, pneumatic or hydraulic cylinder, or the like.
• FIG. 6A illustrates ahospital bed90 comprising a plurality of bed rails92 and a plurality of bed posts94. Thesharp guard dispenser40 can be attached to one of the bed rails92 for easy access by medical personnel.
• FIG. 6B illustrates abed stand100 with thesharp guard dispenser40 attached thereto. Attachment to thebed stand100 is performed by means of a clamp, clip, Velcro, adhesive, or other fastening method. The attachment is reversible in that thedispenser40 is removed once it is empty and thedispenser40 can be replaced by one containing at least onesharp guard10.
• FIG. 7A illustrates areceptacle60 for usedsharp guards10, comprising acase62, a plurality ofopenings64, anoptional window66, a bracket or mount67, and alid closure68. Thesharp guard10 is shown comprising the medicalsharp object30. Thereceptacle60 is sized to fitsharp guards10 and used entrappedmedical sharps30.
• In an embodiment, thecase62 of thereceptacle60 is fabricated from materials including, but not limited to, polyvinyl chloride, polyethylene, polypropylene, polyester terephthalate (PET), acrylonitrile butadiene styrene (ABS), polystyrene, copolymers of the aforementioned, metal, sealed wood, cardboard, or any other material suitable for a container. The preferred material is PET, cardboard, or polystyrene because of the low manufacturing cost of these materials. Preferred manufacturing methods for thecase42 include, but are not limited to, lamination, blow molding, extrusion, injection molding, or the like. The bracket or mount67 comprises releasable or non-permanent adhesives, magnets, Velcro, clips, clamps, snaps, bayonet mount, screw mounts, or the like.
• In an embodiment, theoptional window66, which can be either open or sealed with transparent polymer, allows the user to visually monitor the contents and fill level.
• In another embodiment, thereceptacle60 further comprises aseal124. In an embodiment, theseal124 is located on thelid closure68. When themedical sharps receptacle60 is full, the user closes thelid68 and enables theseal124 to prevent thereceptacle60 from opening. Thereceptacle60 is then discarded. By this means, a user cannot attempt to discard a usedsharp guard10 in thefull receptacle60, as theopening64 is sealed shut.
• FIG. 7B illustrates thereceptacle60 with thesharp guard10 inserted into everyopening64. Not only can the user see that eachopening64 is filled with thesharp guard10, but it is impossible to put additionalsharp guards10 into thereceptacle60 because all theopenings64 are obstructed by thesharp guard10. In an embodiment, thereceptacle60 further comprises an optional permanent adhesive on its interior wall opposite theopenings64. Once the user inserts thesharp guard10 into thereceptacle60, the adhesive adheres thesharp guard10 to the wall, and prevents removal of thesharp guard10.
• Referring toFIG. 1C, in another embodiment, theadhesive catalyst32 promotes bonding between thesharp guard10 and the adhesive within thereceptacle60 to further prevent removal of the usedsharp guard10 from thereceptacle60.
• FIG. 8 illustrates another embodiment of thereceptacle60 forsharp guards10, comprising thecase62, a single opening120, thewindow66, the bracket or mount67, and thelid closure68. Thelid closure68 further comprises a latch or lock122. Thesharp guard10, shown comprising the medicalsharp object30, is being inserted into the opening120. Thewindow66 permits viewing of the contents of thereceptacle60 when thelid closure68 is closed. Thecase62 constrains an internal chamber that is accessed by theopening64 and permits storage ofsharp guards10 with embeddedmedical sharps30.
• Thelid closure68 is preferably biased open by a spring. The spring may be a leaf spring, a coil spring, or any other type of spring. The latch or lock122 is operable by simple pressure with a single finger. Depression of thelock122 causes thelid closure68 to open by stored force in the spring and permits usedsharp guards10 with embeddedsharps30 to be placed or disposed of within thecase62. Such a latch or lock122 is, in a preferred embodiment, a simple molded catch or protrusion that engages with a feature on thecase62 and prevents thelid closure68 from opening. Depression of the latch or lock122 causes the catch or protrusion to become disengaged with thecase62 and allows the spring to move thelid closure68 to the open position. Thelid closure68 may then be closed with a single hand and the latch or lock122 engages with thecase62 when thelid closure68 is pushed closed. The stored force to open thelid closure68 may be generated by methods such as, but not limited to, a spring, a magnet, a motor, hydraulic or pneumatic pressure, or the like.
• In another embodiment of thereceptacle60, a specialized lid is configured to clamp to the top of a trashcan or standard medical sharps container. The specialized lid is designed to allow the singlesharp guard10 and encased sharp30 to be inserted into thereceptacle60. The specialized lid prevents overfilling of thereceptacle60 by becoming unable to open when the interior space of thecase62 is full.
• In another embodiment, the user can discard the used, employedsharp guard10 in any standard biohazard waste disposal container.
• FIG. 9A illustrates an oblique view of a sharpguard delivery system80 comprising thedispenser40 and thereceptacle60. Thedispenser40 further comprises the plurality ofsharp guards10 and thereceptacle60 is shown with the single usedsharp guard10 being inserted therein. The usedsharp guard10 further comprises the contaminated medicalsharp object30. Thedelivery system80 allows for access tosharp guards10 and a convenient place for storage of usedsharp guards10 so that the medical practitioner or user does not have to travel across the room to dispose of the medicalsharp object30 orsharp guard10. The unitary design of the sharpguard delivery system80 occupies minimum space in the medical facility. In an embodiment, the sharpguard delivery system80 is unitary. In another embodiment, the sharpguard delivery system80 comprises thedispenser40 and thereceptacle60 as separate units. In an embodiment, thesharp guard receptacle60 holds at least as manysharp guards10 and contaminated medicalsharp objects30 as thedispenser40 contains when full. Thedispenser40 presents onesharp guard10 at a time, and upon removal of the presentedsharp guard10, thedispenser40 presents anothersharp guard10 for use.
• FIG. 9B illustrates another embodiment of the sharpguard delivery system80 comprising thedispenser40, thereceptacle60, and abracket126 to hold thedispenser40 and thereceptacle60. Thebracket126 further comprises a plurality ofrecesses128 to hold thereceptacle60 and thedispenser40. In addition, thebracket110 comprises aclamp130. Theclamp130 is configured to hold thebracket126 to a wall, bed stand, bed rail, ambulance wall, tabletop, or other hospital or medical location. Theclamp130 is configured in various ways including, but not limited to, a releasable adhesive, Velcro, C-clamp, permanent or electro-magnet, bracket with spring-loaded closure, and the like.
• In yet another embodiment of the invention, a bracket is provided that holds thedispenser40 and thereceptacle60. The bracket allows each of thedispenser40 and thereceptacle60 to be inserted and locked into place. Removal of theempty dispenser40 and thefull receptacle60 is accomplished by releasing the lock and removing either thedispenser40 or thereceptacle60 from the bracket. The bracket may be attached to a bed, bed stand, table, wall or the like and reversibly accept thedispenser40 and/or thereceptacle60. The bracket may also allow thedispenser40 to be coupled to a commercially available receptacle.
• In an embodiment, this invention comprises the methods of placing asharp guard10 or other medical sharps receiver at a location proximate to where it will be used medically, or at the point-of-use. It is preferable that such proximate location is no further than 15 feet from where the sharp30 is used and, more preferably, the location is less than 5 feet from where the medical sharp is used. Most preferably, such proximate locations is such that the medical professional does not have to move his feet or even turn to reach asharp guard10 from where the medical sharp30 is used on a patient.
• Thereceptacle60 is preferably located proximate to the patient use of the medical sharp30. Thesharp guard10 is provided by thedispenser40 affixed proximate to where the medical sharp30 is used on the patient. The sterilesharp guard10 may also be taken from another location and moved to the sterile field where it is available for use immediately after using the sharp30 on a patient. The person disposing of the sharp30 entraps the medical sharp30 within thesharp guard10 at or near the point-of-use so that the medical sharp30 is not moved around the room in such a way as it might cut or puncture another person. Once entrapped within thesharp guard10, the healthcare worker transports the medical sharp30 to thereceptacle60 where it is safely discarded.
• FIG. 10 illustrates an embodiment of a packagedsharp guard1000 comprising asharp guard1002 enclosed and sealed within itsaseptic packaging1004. Theaseptic packaging1004 comprises a microbeimpermeable pouch1006 closed with a plurality ofseals1008, and further comprising anopening tab1010.
• Referring toFIG. 10, the microbeimpermeable pouch1006 can be fabricated from two layers of material such as, but not limited to, metal foil, polyester, PETG, Tyvek®, and the like. Theseals1008 can be heat seals or they can be integrally formed folds in thepouch1006. The heat seals1008 can be created by a heater applying heat and pressure for a period of time sufficient to melt two layers ofpouch1006 or material together. The width of theseals1008 can range from about 0.05 inches to 1.0 inches and preferably around 0.375 inches. Theopening tab1010 can be an unsealed edge region that permits an operator to separate the material layers and gain enough grip to pull theseals1008 apart. In an embodiment where gas such as ethylene oxide is used for sterilization, a gas permeable pouch comprising at least one layer fabricated from Tyvek® or similar is beneficial. If radiation sterilization is used, for example gamma irradiation or electron beam irradiation, a dosage of about 25 to 40 kiloGrays (kGray) is generally suitable to provide a sterility assurance level (SAL) of 1 in a million (10⁻⁶). A second aseptic package (not shown) surrounding the packagedsharp guard system1000 can increase sterility assurance and improve delivery to the sterile field.
• FIG. 11A illustrates an embodiment of the opensharp guard device1002, following removal from itsaseptic packaging1004. Thesharp guard1002 comprises alower shell1102, anupper shell1104, ahinge1106, alatch1108, a locking detent orlatch hook1110, a puncture resistant liner orinner barrier1112, alower foam pad1116, and anupper foam pad1114 further comprising anadhesive layer1128 and acover strip1130. Thelower foam pad1116 further comprises an imprintedlabel1134 and aneedle re-capping station1136. Thesharp guard1002 further can be provided with a separate sealing foam orgel1140.
• Referring toFIG. 11A, thesharp guard device1002 is configured for minimum cost and maximum utility in the medical environment. Theupper shell1104 and thelower shell1102 can both be affixed to each other by thehinge1106. Thehinge1106 can be integral to, or separately attached to theupper shell1104 and thelower shell1102. Thelatch hook1110 can be affixed to, or integral to, theupper shell1104. Thelatch1108 can be integral to, or affixed to, thebottom shell1102. Thelatch1108 can be affixed to thebottom shell1102 by welding, bonding, hinge pins, fasteners, or the like. Thehinge1106 can, be configured as a simple fold, or it can comprise a plurality of folds such as in a “Z” fold. Thehinge1106 can comprise areas of variable thickness to enhance flexibility. Thehinge1106, in a preferred embodiment, can be configured to maintain theupper shell1104 and thelower shell1102 flat and stable prior to closure. Thehinge1106, in a preferred embodiment, retains theupper shell1104 and thelower shell1102 open and opposed to each other and laying substantially flat against a flat surface, such as a table top or countertop. Thehinge1106 in its flat, open, embodiments allow thesharp guard1002 to remain highly stable in its open, resting position. In some embodiments, theflat hinge1106 can be formed by first thermoforming or molding a flat web between thelower shell1102 and theupper shell1104. A secondary operation can then be performed to either melt, cut, stamp, or otherwise form a groove or thin area in the web to enhance flexibility and allow thehinge1106 to lie flat when theupper shell1104 and thelower shell1102 are open but still close easily and without resistance.
• The exposed surface theupper pad1114, which can also be termed a foam pad, a pad, a foam block, a block, a space filler, or the like, can comprise a highlyaggressive adhesive layer1128 capable of gripping medical devices embedded therein with a high degree of friction or adhesiveness. Theadhesive pad1128 can further comprise a plurality ofholes1132 that completely penetrate theadhesive layer1128 to allow fluids to be absorbed by the opencell foam pad1114. Theadhesive layer1128 can also be termed a film, a pad, an intermediary, or other suitable descriptor. Theadhesive layer1128 can be advantageously provided with aremovable cover strip1130, shown partially pulled up and off theadhesive layer1128, and fabricated from low friction materials such as polyethylene, polypropylene, PTFE, and the like, wherein thecover strip1130 can be removed prior to use by the operator. Thecover strip1130 can be fabricated inexpensively with materials such as paper treated, coated, embedded with, sprayed on, or dipped in, silicone release agent, silicone oil, or the like. The low friction treatment of thecover strip1130 is preferably applied only to one side, the side that contacts the adhesive1128. Thecover strip1130 can be provided with instructions, labels, and other information to minimize the need for additional instructions within the device packaging and it can be provided with a grip tab for easy grasping and removal. Thecover strip1130 can also be termed a liner.
• Thelower foam pad1116 can also be termed a foam pad, a pad, a foam block, a block, a space filler, or the like. Thelabel1134 can be adhered to or directly imprinted upon thelower foam pad1116. Processes suitable for printing on open-celled foam are appropriate for thislabel1134. Such processes include, but are not limited to, sublimation printing, inkjet printing, silkscreen printing, and the like. Thelabel1134 can comprise information such as, but not limited to, symbols indicating where to insert the medical sharps, the location of a re-capping station, specifications for the maximum size of medical sharps to be inserted, the orientation of insertion, a region for counting needles, and the like.
• Thelower shell1102, theupper shell1104, thehinge1106, and, optionally thelatch1108 and thelatch hook1110 can be manufactured from a sheet extrusion of polymer, injection molding, or the like. Sheet extrusion converts thermoplastic pellets or powder into continuous, controlled thickness, rolls of single or multi-layer materials (co-extrusion), which are suited for further processing. The sheets are then re-softened and molded by air pressure or vacuum to define the part's interior and exterior shape in a process called thermoforming, pressure forming, or vacuum forming. Features such as hinges, latches, detents, seals, and the like can all be produced integral to thelower shell1102, theupper shell1104, or both.
• FIG. 11B illustrates a side view of thesharp guard device1002 as viewed from the end where syringe barrels are inserted. Thesharp guard device1002 comprises thebottom shell1102, theupper shell1104, thelatch hook1110, thelatch1108, thehinge1106, and thelatch hinge1118.
• Referring toFIG. 11B, thelatch1108 is affixed to thebottom shell1102 by thelatch hinge1118. Thelatch hinge1118 can be a fatigued region of polymer, it can comprise hinge pins and holes, it can comprise a thin region of polymer, it can comprise a ball and socket, it can comprise an arcuate bend in the polymeric material, it can comprise a “Z” fold, and the like. Thehinge1106 and thelatch hook1110 preferably are fabricated from the same materials as thelower shell1102 and theupper shell1104. Thebottom shell1102, theupper shell1104, thehinge1106, thelatch1108, and thelatch hook1110 can all be fabricated at the same time using a single process such as, but not limited to, injection molding, thermoforming, vacuum molding, and the like. Thebottom shell1102, theupper shell1104, thehinge1106, thelatch1108, and thelatch hook1110 can comprise materials such as glycol modified PET (PETG), PET, polyurethane, polysulfone, PEEK, polyethylene, HDPE, LDPE, polypropylene, and the like. The materials can be co-extruded to generate multi-layer structures or multi-component multi-layer structures. The thickness of thebottom shell1102 and thetop shell1104 can range between approximately 0.005 inches and 0.125 inches with a preferred range of approximately 0.020 to 0.050 inches.
• FIG. 11C illustrates an oblique view of thesharp guard device1002. Thesharp guard1002 comprises thelower shell1102, theupper shell1104, thelower pad1116, theupper pad1114, thelower opening1122, theupper opening1120, and thelatch1108. Thelower shell1102 further comprises a sealingflange1124 and theupper shell1104 further comprises the sealingreceiver1126. The sealingflange1124 and the sealingreceiver1126 can further comprise snap features that permit a small or substantial degree of tactile closure and locking. The snap features can also provide a degree of audible closure feedback. The sealingflange1124 can comprise projections (not shown) that engage, mate, and lock with detents in the sealingreceiver1126.
• Referring toFIG. 11C, thelower pad1116 and theupper pad1114 are inserted into thelower shell1102 and theupper shell1104, respectively. Thepads1114 and1116 can be affixed by a slip fit, a press fit, a heat welded attachment, an ultrasonically welded attachment, or be adhesively bonded to theirrespective shell structures1104 and1102. Thepads1114 and1116 are preferably fabricated from memory foam. That is, thepads1114 and1116 can be fabricated from foam that has little recovery force. When the foam becomes deformed, it remains deformed with little or no substantial spring-back. Suitable foam structures include those fabricated from polyurethane foam, polycarbonate foam, and the like. Open-cell, closed-cell, and partially open cell foam structures can be suitable for the application. An open-cell structure has at least one surface comprising interconnected cells with open ends to allow any residual biological fluids to coalesce and flow into the interior absorptive layers of the foam. The surface is preferentially slightly tacky with a high coefficient of friction to hold and support medical instrument barrels and handles so that they cannot slide or be pulled from the grip of the foam. The external surface of the foam structure, along all surfaces except the open central area of the top and bottom, is preferably closed-cell so that the foam forms a fluid-tight barrier to liquids contained therein. It is especially beneficial that the foam is closed at thelower opening1122 and thetop opening1120.
• In other embodiments, a separate sealing foam orgel1140 can be provided at thelower opening1122 and theupper opening1120 to further secure the opening area against fluid leakage. Thefoam pads1114 and1116 can also comprise gel materials to form structures with an exceedingly high degree of conformability to inserted medical sharp devices. Exemplary foam for thepads1114 and1116 can comprise low-density flexible, polyester urethane foam or similar material with a light compression deflection to conform to individual medical instrument shapes. The density can advantageously range between about 2.0 and 6.0 pounds per cubic foot.
• Thelower opening1122 and theupper opening1120 can be configured such that when theupper shell1104 is closed against thelower shell1102, a final opening is configured to fit certain medical devices. In an exemplary embodiment, the composite opening comprising thelower opening1122 and theupper opening1120 is just wide and tall enough to pass two 20-cc syringes aligned side by side. In another embodiment, the composite opening can be sized to pass two 10-cc syringes, one 60-cc syringe, two 5-cc syringes, one 20-cc syringe, one 10-cc syringe, one 5-cc syringe, or no syringe at all (no opening). In yet another embodiment, thesharp guard1002 comprises either anupper opening1120 or alower opening1122, but not both.
• In the no opening embodiment, the sealingflange1124 engages the sealingreceiver1126 around the entire perimeter of thesharp guard device1002. The sealingflange1124 can comprise a molded feature in thelower shell1102 and the sealingreceiver1126 can comprise a molded feature in theupper shell1104.
• In another embodiment, the sealingflange1124 or the sealingreceiver1126, or both, can further comprise an O-ring or gasket (not shown) fabricated from a soft polymer capable of completely forming a fluid-tight seal between the sealingflange1124 and the sealingreceiver1126. The gasket (not shown) can be used on the complete sealing embodiment or in embodiments comprising theupper opening1120 and thelower opening1122.
• FIG. 12A illustrates a top view of thesharp guard device1002 in with thetop shell1104 closed against the bottom shell (not shown). Thelatch1108 is closed and irreversibly engaged with thelocking detent1110. Thesharp guard1002 further comprises thehinge1106 and alabel1206.
• Referring toFIG. 12A, thelatch1108 has been rotated about its hinge (not shown) and has been resiliently deformed as it is advanced over a ramp in thelocking detent1110 past a sharp wall (not shown) wherein it resiliently returns to its original unstressed configuration. Thelatch1108 is configured such that there is negligible or no opening available between it and the upper shell for an individual to grip, obtain purchase on the latch, or pry thelatch1108 and pull it open, following closure.
• FIG. 12B illustrates a side view of the closedsharp guard1002 further comprising thelower shell1102, theupper shell1104, thehinge1106, thelower opening1122, theupper opening1120, thelatch1108, thelocking detent1110, theupper foam pad1114 and thelower foam pad1116.
• Referring toFIG. 12B, the closedsharp guard1002 is configured to meet all standard requirements for final disposal of medical sharps, prior to being discarded in the red biohazard bags. This includes an inability to re-open and access the disposed medical sharp (not shown), high resistance to puncture, and a fluid-tight seal such that contaminated medical waste does not leak from thesharp guard1002.
• In embodiments wherein thesharp guard1002 comprises theupper opening1120, thelower opening1122, or both, thefoam pads1114 and1116 come together when theupper shell1104 closes against thebottom shell1102. Theupper foam pad1114 compresses and seals against thelower foam pad1116 to form a fluid tight seal in the window area and, optionally, around the entire periphery of thedevice1002.
• In some embodiments, thesharp guard1002 can further comprise an absorbent volume or layer, internally disposed either within thefoam pads1116,1114, or both, or surrounding thefoam pads1116,1114. In yet other embodiments, the absorbent material can be dispersed somewhat evenly or unevenly, throughout thefoam1114,1116. Such absorbent material can comprise methylcellulose, hydrophilic gels or polymers, aerogel, or the like. Materials developed for, and used in the construction of, diapers, absorbent pads, tampons, sanitary pads, and the like can be advantageously used in thesharp guard1002.
• FIG. 12C illustrates an oblique view of the closedsharp guard1002. Thesharp guard1002 comprises theupper shell1104, thelower shell1102, thelatch1108, thelocking detent1110, theopening1202, thelower foam pad1116, theupper foam pad1114, and thelabel1206.
• Referring toFIG. 12C, theopening1202 is a composite opening and comprises theupper opening1120 and thelower opening1122 ofFIG. 12B. The closedsharp guard1002 is suitable for deposit in a biohazard bag and completely protects individuals from contamination by the used medical sharp devices contained therein.
• Thesharp guard1002 can further comprise an inner barrier or liner1112 (Refer toFIG. 11A) disposed between thelower foam pad1116 and thelower shell1102 and, optionally, between theupper foam pad1114 and theupper shell1004. The inner barrier orliner1112, in an exemplary embodiment, can comprise a mat produced from a variety of fibrous materials such as, but not limited to, cotton, cellulose, and synthetic materials including thermoplastics and polyurethanes. The mat layer can range in thickness between about 1/32 and ¼ inch and preferably between about 1/16 and ⅛ inch. The weight of the mat layer can range between about 1 to 10 ounces per square foot with a preferred range of about 3 to 5 ounces per square foot. The inner barrier orliner1112 serves as a secondary puncture-resistant layer that complements theshells1102 and1104 and provides additional puncture resistance beyond that achievable with the thin polymerouter shells1102 and1104. The inner barrier orliner1112 can be pre-folded and fitted to snugly insert within and entirely, or partially, line the interior surfaces of thelower shell1102 and theupper shell1104.
• FIG. 13A illustrates an embodiment of asharp guard1002 further comprising the lowerfoam insert label1134 imprinted on thelower foam block1116. Thesharp guard1002 comprises thelower shell1102, theupper shell1104, thehinge1106, theupper foam block1114, the upper adhesive layer (not shown) and therelease paper1130. Thesharp guard1002 further comprises a puncture resistantsecondary barrier1112. Thefoam insert label1134 comprises one or moresyringe orientation markers1302, aneedle re-capping feature1136, and aneedle counting area1304.
• Referring toFIG. 13A, thefoam insert label1134 can preferably be imprinted on the surface of thelower foam block1116 but could also be imprinted on the surface of theupper foam block1114, in an other embodiment. Thefoam insert label1134 can be imprinted directly on thefoam1116 or it can be applied as a secondary layer by adhesive or welding means. Thefoam insert label1134 can, in another embodiment, be covered by a transparent, or semi-transparent, lower adhesive layer (not shown). Thus thefoam insert label1134 can be sandwiched between foam and adhesive on the bottom, the top, or both parts of thesharp guard1002. Theneedle counting area1304 can be an imprinted pattern of rectangles, triangles, circles, or other geometric designs umbered sequentially to permit the user to embed, place, or insert needles in groups so that they may be more easily counted and accounted for. In the illustrated embodiment, theneedle counting area1304 comprises a series of ten rectangles numbered1 through10. The rectangles can be directly imprinted on thefoam1116, in the illustrated embodiment. The user can stick the needle end in the foam or adhere the needle to an adhesive region, or any other suitable means of fixing the needle within the geometric pattern in the desired location. Because the pattern is counted, a user can quickly verify the number of sharp items inside each of the pattern units and organize and account for all the used, contaminated, medical sharps.
• FIG. 13B illustrates an embodiment of an opensharp guard1002 further comprising theneedle re-capping station1136 being used to re-cap asyringe needle1308. Thesharp guard1002 further comprises thelower foam pad1116, thelower shell1102. In the illustrated embodiment, thesyringe needle1308, or hypodermic needle, is affixed to the distal end of asyringe1310 and aneedle cap1306 is illustrated pushed down into theneedle re-capping station1136 so that its proximal, open end is pointing up.
• Thelower foam pad1116 can comprise features suitable for needle re-capping. Theneedle re-capping feature1136 can comprise a hole in thefoam pad1116 or it can comprise an X-slit penetrating down into thefoam pad1116, as illustrated. A user can replace theprotective cap1306 over a hypodermic needle that has had its cover removed by inserting the cap closed end into the needle recapping station or feature1136 with the open end of the cap up. Thesyringe needle1308 can then be inserted into the open end of thecap1306 without the risk of sticking the operator in the hand during the recapping procedure, an all too common occurrence in the medical workplace.
• FIG. 14A illustrates an embodiment of thesharp guard1400 wherein thesharp guard1400 forms part of the initial packaging of a dedicated medical sharp1440 further comprising asharp needle1442. Thesharp guard1400 comprises abottom shell1402, atop shell1404, ahinge1406, alatch1408, alatch catch1410, aninner void1436 configured to accept, hold, and secure the dedicated medical sharp1440. Thesharp guard1400 can further comprise the optional bottom punctureresistant barrier1432, the top punctureresistant barrier1434, or both.
• Referring toFIG. 14A, in the illustrated embodiment, the dedicated medical sharp1440 is an auto-injector used for self-injection of drugs such as, but not limited to, anthrax vaccine, epinephrine, toxin antidotes, insulin, low molecular weight heparin, and the like. Thehypodermic needle1442 can be provided exposed, as illustrated, or it can comprise a closure that serves as an aseptic enclosure (not shown) for theneedle1442. Thus, thesharp guard1400 can be provided in a sterile pouch or package from which it is removed prior to use, or it can be provided non-sterile but containing a sterilized, aseptically protected dedicated medical sharp1440. The user removes the dedicated medical sharp1440 from thesharp shell1400. The dedicated medical sharp1440 can be pre-filled with pharmaceutical agents, preferably sterile, or the dedicated medical sharp1400 can be filled by the user. Following use of the dedicated medical sharp1440, it is returned to the inner void of thesharp guard1440, wherein thesharp guard1440 is then closed and locked to entrap and sequester the used medical sharp1440 therein.
• FIG. 14B illustrates an embodiment of thesharp guard1400 following closure around a used, dedicated medical sharp. Thesharp guard1400 in its closed position is illustrated with theupper shell1404, thehinge1406, thelatch1408, and thelatch catch1410 showing. The closedsharp guard1400 is puncture-resistant, locked closed such that it cannot be reasonably re-opened, even if grossly deformed or crushed, and sealed against leakage of liquid enclosed therein. The materials used in fabrication of the dedicatedsharp guard1400 can be the same or similar to those used in fabrication of the more universally applicablesharp guard1102. The dedicatedsharp guard1400 can further comprise absorbent layers, perimeter seals, multiple locks or latches, foam inserts, adhesive layers, or any of the other features shown in the universalsharp guard1102. The dedicatedsharp guard1400 can be provided in a single pack, as illustrated, or it can be provided in multiples such as two to a package, three to a package, or any other convenient number. The dedicatedsharp guard1400, in some multiple device embodiments, can have individual closure means or it can have a single closure to seal the unit after all of the plurality of devices have been returned to their proper storage location. In the multiple unit configuration or embodiments, for example, a person might use four insulin syringes in a day and keep the container open until the fourth unit at the end of the day, has been returned to its form fitting void within thesharp guard1400. Following return of the fourth insulin syringe, the lid can be closed, sealed and locked pending final disposal with other hazardous waste.
• FIG. 15 illustrates a lateral cross-sectional view of a closedsharp guard1002 further comprising an absorbent region orpad1502 and aseal gasket1504 around the perimeter. Thesharp guard1002 also comprises thelower shell1102, theupper shell1104, thehinge1106, theadhesive layer1128, theupper foam block1114, and thelower foam block1116. Further illustrated is a plurality ofsyringes1310 inserted into thesharp guard1002.
• Referring toFIG. 15, theseal gasket1504 can be affixed to thelower shell1102 or theupper shell1104. A second, or more,seal gasket1504 can be comprised by theupper shell1104, thelower shell1102, or both, for additional insurance against fluid leakage from the closedsharp guard1002. Theseal gasket1504 can comprise a round, rectangular, triangular, or other suitable geometric shape, in cross-section. Theseal gasket1504 can ride within a detent in theupper shell1104 or thelower shell1102 and it can further seal within a detent on the complementary shell surface to provide a tactile sense of closure and a reduced risk of re-opening. Theseal gasket1504 can comprise materials such as, but not limited to, silicone elastomer, latex rubber, gel, closed-cell polyurethane or polyethylene foam, polyurethane, thermoplastic elastomer, or the like. The material hardness can range between5A and90A with a preferred range of 5 A to 60 A. Theseal gasket1504 or its mating surface on either theupper shell1104 or thelower shell1102 can further comprise an adhesive to provide additional gap filling and resistance against re-opening. Theseal gasket1504 can completely surround the perimeter of thelower shell1102, theupper shell1104, or both. In other embodiments, theseal gasket1504 can partially surround the perimeter of theupper shell1104, thelower shell1102, or both. For example, inFIG. 11C, the seal gasket would not span theopenings1120 and1122.
• Theabsorbent pad1502 can be a layer embedded within thelower foam block1116, theupper foam block1114, or both. In other embodiments, theabsorbent pad1502 can be configured as a surround layer that parallels the interior walls of thelower shell1102, theupper shell1104, or both. Theabsorbent pad1502 can be embedded within the foam, as illustrated, or it can be trapped between theupper foam1114 and theupper shell1104 or thelower foam1116 and thelower shell1102. In yet other embodiments, theabsorbent pad1502 can comprise a plurality of small cells or volumes embedded or dispersed within thefoam1114 and1116. In another embodiment, thefoam1114,1116, or both, can comprise widely disseminated or disperse micro-volumes of absorbent material within their structures. The material comprised by theabsorbent pad1502 can include materials such as, but not limited to, sugar, cellulose, sponge, methyl cellulose, hydrophilic hydrogel, kitty litter, or the like. Theabsorbent layer1502 can function to receive and store liquids shed from an entrapped, contaminated sharp and maintain those liquids within thesharp guard1002 prior to destruction.
• FIG. 16 illustrates an oblique view of thesharp guard device1600. Thesharp guard1600 comprises thelower shell1102, theupper shell1104, thelower pad1116, theupper pad1114, thelower opening1122, theupper opening1120, and thelatch1108. Thelower shell1102 further comprises a sealingflange1124 and theupper shell1104 further comprises the sealingreceiver1126. The sealingflange1124 and the sealingreceiver1126 can further comprise snap features (not shown) that permit a small or substantial degree of tactile closure and locking. The snap features (not shown) can also provide a degree of audible closure feedback. The sealingflange1124 can comprise projections (not shown) that engage, mate, and lock with detents in the sealingreceiver1126. Thesharp guard1600 further comprises a lower unsealed volume orspace1612, an upper unsealed volume orspace1610, anupper separation bulkhead1608, alower separation bulkhead1606, a lower sharp disengagement orremoval panel1604, an upper sharp disengagement orremoval panel1602, each of which comprise a plurality of sharp disengagement orremoval receptacles1614. Referring toFIG. 16, thesharp guard1600 can comprise a single unsealed volume, for example1610 or1612, or thesharp guard1600 can comprise both the upper unsealedvolume1610 and the lower unsealedvolume1612, as illustrated. Theexit seal material1140 is affixed near thebulkheads1606 and1608 and prevents liquid from leaking from the region of thepads1114 and1116 into the unsealed area orvolume1610,1612 through thewindows1120 and1122. Following removal of sharps from handles, syringe barrels, etc., remaining unsharp ends of the sharps project through theopenings1120 and1122 and need to be sealed by theexit seal1140. The advantage of this system is that a person cannot touch the portions of the sharps that project out of thepads1114 and1116. Thelower shell1102 and theupper shell1104 can be considered to extend from the far wall, as illustrated to thebulkheads1606,1608. The unsealedvolume1610 and1612 are surrounded on by additional materials orwalls1618 and1620 on the bottom portion and top portion of thesharp guard1600 respectively. The additional material orsurround shield walls1618 and1620 can be affixed to thebulkheads1608 and1606 or to thebottom portion1102 and thetop portion1104.
• Application of the sharp guard system and methods reduces the risk that a medical caregiver will use a hypodermic needle, scalpel, or the like on a patient, turn around and accidentally stab a co-worker while trying to put the sharp into its receptacle. Such a scenario is particular disadvantageous when the patient is a vector for highly pathogenic organisms such as those for hepatitis, human immunodeficiency virus (HIV), and the like. The sharp guard system is universal and does not require that each individual sharp is specially designed to retract or self-blunt. The sharp guards and the methods of using the sharp guards reduce the risk of an inadvertent contamination in the medical environment. The sharp guard system can be provided within a hospital, emergency vehicle, or medical center but it can also be provided at any point of use outside a hospital or traditional medical center where medical intervention is provided.
• The present invention may be embodied in other specific forms without departing from its spirit or essential characteristics. For example, the sharp guard can, instead, be configured as a single monolithic slab of gel material that entraps the sharp and hardens to embed the sharp. The sharp guard receptacle and dispenser may also be configured to accept such hardenable gel sharp guards. The described embodiments are to be considered in all respects only as illustrative and not restrictive. The scope of the invention is therefore indicated by the appended claims rather than the foregoing description. All changes that come within the meaning and range of equivalency of the claims are to be embraced within their scope.

Claims (20)

1. An apparatus adapted for entrapment and disposal of contaminated medical sharps comprising:

a shell defining a sealed volume having an upper portion and a lower portion, wherein the shell comprises a first, open position and a second, closed position;

a pre-defined hinge connecting the upper portion to the lower portion;

wherein an inside surface of at least one of the lower portion and the upper portion comprises a raised barrier surrounding the sealed volume, the raised barrier substantially extending inside a perimeter of at least one of the upper portion and the lower portion in the region of the sealed volume, wherein the raised barrier is adapted to prevent a contaminated medical sharp from puncturing across an interface between the upper portion and the lower portion of the closed shell;

an opening located along an edge of at least one of the upper portion and the lower portion defining a break in the raised barrier, the opening configured to allow a blunt portion of the medical sharp to project out of the sealed volume when the shell is closed;

a first pad affixed to an inside surface of the lower portion, the first pad comprising a first gap-filling deformable layer disposed within the inside surface of the lower portion;

a first seal configured to prevent leakage from the sealed volume when the upper portion is closed against the lower portion;

a second seal configured to prevent fluid leakage through the opening from the sealed volume when the shell is closed around used medical sharps, the blunted portions of the used medical sharps having random cross-sectional shapes, projecting through the opening; and

an adhesive region set in a depression within the sealed volume substantially surrounded by the raised barrier.

2. The apparatus ofclaim 1 wherein the first pad further comprises absorbent material.

3. The apparatus ofclaim 1 further comprising a cover strip releasably affixed to the surface of the adhesive region.

4. The apparatus ofclaim 1 further comprising a second pad affixed to an inside surface of the upper portion in the sealed volume.

5. The apparatus ofclaim 1 wherein the first pad further comprises an adhesive layer.

6. The apparatus ofclaim 4 wherein the second pad further comprises an absorbent material.

7. The apparatus ofclaim 3, wherein the cover strip comprises a pull tab.

8. The apparatus ofclaim 1 wherein the lower portion further comprises a puncture resistant lip wherein the lip substantially surrounds the inside surface of the lower portion, wherein the lip shields an interface line where the upper and lower portions meet such that the interface line is resistant to puncture by medical sharps.

9. The apparatus ofclaim 1 wherein the first pad, the second pad, or both, comprise open cell foam.

10. The apparatus ofclaim 1 further comprising a non-re-openable, irreversible lock to maintain closure of the shell.

11. The apparatus ofclaim 1 further comprising a secondary puncture resistant barrier inside the shell.

12. The apparatus ofclaim 1 wherein the first pad, the second pad, or both comprise closed cell foam adjacent to the shell.

13. The apparatus ofclaim 1 wherein the lower gap-filling foam pad is imprinted with a label.

14. The apparatus ofclaim 1 wherein the lower gap-filling foam pad further comprises a needle counting area.

15. The apparatus ofclaim 1 wherein the lower gap filling foam pad comprises a needle re-capping station.

16. The apparatus ofclaim 1 further comprising a first adhesive layer affixed to the inside surface of the upper portion.

17. The apparatus ofclaim 1 further comprising a sharp removal panel affixed to the shell or other structural element, wherein the sharp removal panel comprises features capable of engaging a medical sharp such that the medical sharp can be removed from a handle, syringe barrel, or the like.

18. A method for entrapment and disposal of contaminated medical sharps comprising the steps of:

Providing a shell defining a sealed volume, wherein the shell comprises an upper portion, a lower portion, a pre-defined hinge separating the upper portion and the lower portion, wherein the shell is substantially puncture resistant to medical sharps;

Inserting a used, contaminated medical sharp into a layer of foam affixed to the shell;

Closing the upper portion of the shell against the lower portion of the shell;

Allowing a blunt end of the used, contaminated medical sharp to project out of the shell through a window;

Sealing the blunt end of the used, contaminated medical sharp in the region of the window such that liquid cannot escape the sealed volume;

Sealing the perimeter of the shell in the region where the window is not located;

Adhering the used, contaminated medical sharp to the interior of the shell; Irreversibly locking the upper portion of the shell to the lower portion of the shell; and

Disposing of the used, contaminated medical sharp, with its sharp end trapped within the shell, into hospital medical waste;

Wherein the shell is the barrier against being injured with the sharp end of the used, contaminated medial sharp.

19. A method ofclaim 18 further comprising the step of providing the shell at the point of use of the medical sharp in the medical setting.

20. A method ofclaim 18 wherein the shell is provided in settings outside the hospital or traditional medical center.

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